Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Total Abdominal Hysterectomy
Ultrasound-Guided Transversalis Fascia Plane Block Versus Intrathecal Morphine for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized Clinical Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to compare the ultrasound-guided transversalis fascia plane (TFP) block and intrathecal morphine for postoperative analgesia in patients undergoing total abdominal hysterectomy (TAH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2025
CompletedFirst Posted
Study publicly available on registry
October 1, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2026
CompletedApril 22, 2026
April 1, 2026
6 months
September 23, 2025
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to the 1st rescue analgesia
Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated).
24 hours postoperatively
Secondary Outcomes (3)
Total morphine consumption
24 hours postoperatively
Degree of pain
24 hours postoperatively
Incidence of adverse events
24 hours postoperatively
Study Arms (2)
TFP group
EXPERIMENTALPatients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.
IM group
EXPERIMENTALPatients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery.
Interventions
Patients will receive spinal anesthesia (using 3 mL of hyperbaric bupivacaine 0.5%) + (75 µg morphine diluted in 0.5ml saline) with sham block at the end of surgery.
Patients will receive spinal anesthesia (using 3.5 mL of hyperbaric bupivacaine 0.5%) with bilateral transversalis fascia plane (TFP) block (using 20 mL of bupivacaine 0.25%) at the end of surgery.
Eligibility Criteria
You may qualify if:
- Age from 18 to 65 years.
- American Society of Anesthesiology (ASA) physical status I-II.
- Women undergoing total abdominal hysterectomy (TAH) under spinal anesthesia.
You may not qualify if:
- History of allergies to local anesthetics.
- Local infection at the site of injection.
- Bleeding disorders.
- History of chronic use of analgesic.
- Physical or mental conditions.
- Hepatic, renal or cardiac disease.
- Contraindication to spinal anesthesia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Tanta University
Tanta, 31527, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.
Study Record Dates
First Submitted
September 23, 2025
First Posted
October 1, 2025
Study Start
October 1, 2025
Primary Completion
April 11, 2026
Study Completion
April 11, 2026
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- After the end of study for one year.
- Access Criteria
- The data will be available upon a reasonable request from the corresponding author.
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.